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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Endocervical
510(k) Number K860796
Device Name DISPO-URETTE
Applicant
Roland J. Zwick, Inc.
450 San Antonion Rd., Suite 21
Palo Alto,  CA  94306
Applicant Contact ROLAND J ZWICK
Correspondent
Roland J. Zwick, Inc.
450 San Antonion Rd., Suite 21
Palo Alto,  CA  94306
Correspondent Contact ROLAND J ZWICK
Regulation Number884.1050
Classification Product Code
PCF  
Date Received03/04/1986
Decision Date 04/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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